Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded).

Allergic Bronchopulmonary Aspergillosis Clinical Trial

— NEBULAMB  

Official title:

Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02273661
• Other study ID #: NEBULAMB
• Status: Completed
• Phase: Phase 2
• Start date: November 19, 2014
• Est. completion date: June 28, 2019

Study information

• Verified date: June 2020
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare the incidence of severe clinical exacerbations in the treatment of ABPA, between a strategy with a maintenance treatment and a conventional strategy without antifungal maintenance therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All patients with ABPA justifying an attack treatment with corticosteroids and itraconazole and combining the following criteria:

1. atopic subject or a history of asthma , history of total Immunoglobin E (IgE)> 417 kU / L (or > 210 kU / L with a clear worsening) of a known ABPA), specific Immunoglobin E against Aspergillus fumigatus positive ( >0.35 KUA/L) or positive skin tests.

2. associated with two other of the following criteria: documentation of precipitating antibodies or Immunoglobulin G positive to Aspergillus fumigatus, of radiological infiltrates associated with ABPA (transitional / persistent / bronchial dilation), of blood eosinophilia > 500 elements/mm3.

3. After informing and obtaining consent signed.

Exclusion Criteria:

• Women of childbearing age who do not have an effective contraception for at least 12 first months of the study( 10 months + 2 months of treatment washout) pregnant or lactating women,

• Patient with cystic fibrosis

• Patient with a contra-indication to itraconazole

• Intolerance to ß2 -agonists

• Known hypersensitivity to liposomal amphotericin B or any other component

• Laboratory abnormalities: significant abnormalities of platelet blood count , liver function tests (SGPT, SGOT(serum glutamate oxaloacetate transaminase) , total bilirubin > 5 times the upper limit of the normal range )

• severe renal function impairment (creatinine clearance enf to 30 ml/min)

• Concomitant use of one or more of the following treatments: Alfuzosine, alcaloïdes de l'ergot de seigle vasoconstricteur, aliskiren, astemizole, atorvastatine, avanafil, association Ombitasvir and Paritaprevir, Bepridil, Cisaprid, Dabigatran, dapoxetin, domperidon, dronedaron, Eplerenone, Halofantrin, Ivabradin, Lomitapid, lurasidon, Millepertuis, mizolastin, Pimozid,Quétiapin, quinidin, Ranolazine, ritonavir, Sertindole, sildénafil, simvastatin, sirolimus, Sultoprid, Terfenadine, ticagrelor, triazolam Vardénafil (in men over than 75)

• patient with anti IgE- monoclonal antibody for less than 4 months or with current complications related to previous treatment with anti IgE- monoclonal antibody -

• Ventricular dysfunction demonstrated such as congestive heart failure or a history of congestive heart failure

• Simple aspergilloma, chronic pulmonary aspergillosis, invasive pulmonary aspergillosis

• Respiratory infection aggravating asthma or ABPA

Related Conditions & MeSH terms

• Allergic Bronchopulmonary Aspergillosis
• Aspergillosis
• Cystic Fibrosis
• Pulmonary Aspergillosis

Intervention

Drug:
• Liposomal amphotericin B (Ambisome®)
An aerosol of Liposomal Amphotericin B (Ambisome®) at 25 mg x 1/ week will be administered during 6 months
• placebo
An aerosol of isotonic saline x 1/ week will be administered during 6 months

Locations

Country	Name	City	State
France	Chu de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of first severe clinical exacerbation	Occurrence of severe clinical exacerbation within 24 months following attack treatment, defined by the onset or worsening of dyspnea aggravating the baseline condition that justified: -increased inhalation treatments (inhaled bronchodilators and / or corticosteroids); and / or initiation of systemic corticosteroid treatment; and / or hospitalization; AND persisting for more than 7 days.	within 24 months following the attack treatment,